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Advanced Malignant MesotheliomaPhase 2NCT00365053

PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

A Phase 2 study testing belinostat and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
belinostat and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Jun 2006to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes:
  • Epithelial
  • Sarcomatoid
  • Mixed
  • Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma
  • Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy
Show all 46Show fewer
  • Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy
  • Unresectable disease
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • The sole site of measurable disease must not be located within the radiotherapy port
  • No known brain metastases
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin normal
  • AST/ALT =< 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance >= 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception for 1 week before, during, and for >= 2 weeks after completion of study treatment
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
  • No symptomatic congestive heart failure
  • No congestive heart failure related to primary cardiac disease
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No condition requiring anti-arrhythmic therapy
  • No uncontrolled hypertension
  • No myocardial infarction within the past 6 months
  • No ischemic or severe valvular heart disease
  • No ongoing or active infection
  • No marked baseline prolongation of QT/QTc interval
  • No repeated QTc interval > 500 msec
  • No long QT syndrome
  • No other significant cardiovascular disease
  • No other uncontrolled intercurrent illness
  • No psychiatric illness or social situation that would preclude study compliance
  • Recovered from prior therapy
  • No prior valproic acid or other known histone deacetylase (HDAC) inhibitor
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • More than 3 weeks since prior radiation therapy
  • No concurrent medication that may cause torsade de pointes
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma

This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.

SECONDARY OBJECTIVES:

  1. Determine the overall survival and time to progression in these patients. II. Assess the toxicities associated with this drug in these patients. III. Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response.

OUTLINE:

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection during course 1 of treatment for biomarker correlative studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse transcriptase-polymerase chain reaction as a potential predictive marker for response.

After completion of study treatment, patients are followed periodically.

Being tested
belinostat, laboratory biomarker analysis
Medical subject headings
Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • belinostatDrug

    Also called PXD101

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00365053
Study groupRoleWhat they receive
Treatment (belinostat)ExperimentalPatients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: belinostat; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Overall Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 3 years

  2. Progression-free Survival

    Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Up to 3 years

  3. Toxicity Profile

    Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: Up to 3 years

  4. Apoptosis by TUNEL Assay

    Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

    Measured: At baseline

  5. Histone Acetylation by IHC and Western Blotting

    Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

    Measured: At baseline and at 4 hours after last dose of PXD101 on day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365053
Sponsor's protocol ID
NCI-2012-02839
Other IDs
PHII 67, N01CM62209
Status last verified
May 2018
First submitted
16 Aug 2006
Last updated
7 Jun 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing belinostat and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018; AzTrials last refreshed its copy on 26 Oct 2026.

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